The purpose of this study is to determine the pharmacokinetics and safety of SVG101 (dispersible tab. of everolimus) in healthy volunteers compared to Afinitor tab. after oral administration.
This is a randomized, open-label, single-dose, two-way cross-over study to investigate the Pharmacokinetic characteristics and safety after oral administration of SVG101 (dispersible tablet of everolimus) 5mg and Afinitor 5mg in 26 healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
5mg of SVG101
5mg of Afinitor
Yonsei University Healthcare System, Severance Hospital
Seoul, South Korea
AUCinf of everolimus
Time frame: up to 144 hours
Cmax of Everolimus
Time frame: up to 144 hours
Cmin,ss,pred of Everolimus
Time frame: up to 144 hours
AUClast of Everolimus
Time frame: up to 144 hours
Tmax of Everolimus
Time frame: up to 144 hours
t1/2 of Everolimus
Time frame: up to 144 hours
Vd/F of Everolimus
Time frame: up to 144 hours
Clearance of Everolimus
Time frame: up to 144 hours
Adverse Events (AEs)
Time frame: up to approximately 45 days
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